1. Field of the Invention
The present invention relates to a percutaneous emergent cricothyroidotomy airway device (PECAD) and method for creating a surgical airway when the oral and/or nasal airway cannot be intubated.
2. Description of the Related Art
When a patient has any sort of severe injury, there is a requirement to maintain a reliable and stable airway to the lungs. When paramedics or other emergency professionals face unexpected difficulty in intubation, the main priority is to ensure adequate ventilation and provide the patient with the required level of oxygen needed for survival. Continuous attempts at orotracheal and or nasotracheal intubation can result in bleeding and edema of the upper airway, above the thyroid gland, making the process of tracheal intubation much more difficult and perhaps impossible.
After a few failed attempts, paramedics are advised to move on to a pre-planned failed intubation sequence, such as implementing a surgical airway. A surgical airway is usually performed when orotracheal intubation is unsuccessful or can not be performed. With current methods and devices on the market, there is a large risk associated to creating a surgical airway which makes this process preferably designated for emergency use only.
Some situations in which creating a surgical airway is necessary include major maxillo-facialary injury, oral bums, fractured larynx, or severe damage to the thoracic region. There are currently two methods of performing a surgical airway procedure, the needle or Silenger cricothyroidotomy method and the surgical or formal cricothyroidotomy method.
The Silenger cricothyroidotomy method involves percutaneously placing a relatively large gauge cannula needle into the trachea by penetrating through the cricothyroid membrane. Dilator sheaths are then placed over the needle, allowing the tissue circumventing the needle to expand. A breathing tube can then be inserted over the needle and sheath dilator assembly down towards the lungs. The needle and dilators are then removed giving the patient a temporary airway. See U.S. Pat. Nos. 4,677,978; 4,969,454. This method will allow adequate ventilation for up to 45 minutes. A risk of hypercapnea dictates the time constraint. In the past, this 45 minute time period would allow a patient to remain alive while in transport to a hospital where they were able to be converted to a formal tracheotomy.
A formal cricothyroidotomy or classic surgical airway has been proven in studies to be safer and quicker than performing a formal tracheotomy due to anatomical location and the precision required. The surgical cricothyroidotomy involves making an incision through the cricothyroid membrane, or ligament, and placing a tracheal tube down into the trachea through the hole made in the membrane. See U.S. Pat. No. 4,520,810.
The above is not the preferred technique for children under twelve due to the size of the anatomy. The gap between the cricoid and thyroid cartilage is much smaller in children then adults. Moreover, the cricothyroidotomy usually does not involve the use of local anesthetics due to time constraints and if a patient is asphyxiating, suffocating, or dying.
Some complications arising from the above procedures include but are not limited to: venus transaction, infection, unintended perforation, aspiration of gastric contents, and esophageal perforation. These complications can cause the following: hemorrhaging, decrease in blood pressure, cardiogenic shock, non healing of wounds, antibiotic treatment, extended rehabilitation in hospital, surgical resection, hypoxemia, bradycardia, hemodynamic collapse, cardiac arrhythmia, cardiac arrest, laryngo-tracheal complication, hoarseness, loss of voice, inflammation, pneumonia, gastric intestinal bypass surgery and/or death.
Thus, there is a need for a device that allows medical personnel to perform a cricothyroidotomy procedure faster and safer than conventional methods.